SAFETY DATA SHEET

Ganirelix Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
22223-00022

Date of last issue: 26.09.2023
Date of first issue: 15.10.2014

Section 1: Identification
Product identifier:

Ganirelix Formulation

Recommended use of the chemical and restrictions on use
Recommended use: Pharmaceutical
Restrictions on use: Not applicable
Manufacturer or supplier's details
Company: Organon & Co.
Address:

30 Hudson Street, 33nd floor
Jersey City, New Jersey, U.S.A 07302

Telephone:+1-551-430-6000

Emergency telephone number :+1-215-631-6999

E-mail address

EHSSTEWARD@organon.com:

Section 2: Hazard identification
Classification of the substance or mixture
Reproductive toxicity: Category 1BSpecific target organ toxicity repeated exposure:

Category 1 (Bone marrow, Liver, Adrenal gland, spleen, Ovary)

GHS Label elements, including precautionary statements
Hazard pictograms:

Signal word:

DangerHazard statements:

H360Fd May damage fertility. Suspected of damaging the unborn child.
H372 Causes damage to organs (Bone marrow, Liver, Adrenal
gland, spleen, Ovary) through prolonged or repeated exposure.

Precautionary statements:

Prevention:
P201 Obtain special instructions before use.
P202 Do not handle until all safety precautions have been readand understood.
P260 Do not breathe mist or vapours.
1 / 13

SAFETY DATA SHEET

Ganirelix Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
22223-00022

Date of last issue: 26.09.2023
Date of first issue: 15.10.2014

P264 Wash skin thoroughly after handling.
P270 Do not eat, drink or smoke when using this product.
P280 Wear protective gloves/ protective clothing/ eye protection/ face protection/ hearing protection.
Response:
P308 + P313 IF exposed or concerned: Get medical advice/attention.
Storage:
P405 Store locked up.
Disposal:
P501 Dispose of contents/ container to an approved waste
disposal plant.
Other hazards which do not result in classification
None known.
Section 3: Composition/information on ingredients
Substance / Mixture:

MixtureComponents
Chemical name
Ganirelix

CAS-No.
124904-93-4

Concentration (% w/w)>= 0.01 -< 0.1

Section 4: First-aid measures
Description of necessary first-aid measures
General advice: In the case of accident or if you feel unwell, seek medical advice immediately.
When symptoms persist or in all cases of doubt seek medical
advice.
If inhaled: If inhaled, remove to fresh air.
Get medical attention.
In case of skin contact: In case of contact, immediately flush skin with soap and plentyof water.
Remove contaminated clothing and shoes.
Get medical attention.
Wash clothing before reuse.
Thoroughly clean shoes before reuse.
In case of eye contact: Flush eyes with water as a precaution.
Get medical attention if irritation develops and persists.
If swallowed: If swallowed, DO NOT induce vomiting.
Get medical attention.
Rinse mouth thoroughly with water.
Most important symptoms and effects, both acute and delayed
Risks: May damage fertility. Suspected of damaging the unborn
child.
2 / 13

SAFETY DATA SHEET

Ganirelix Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
22223-00022

Protection of first-aiders:

Date of last issue: 26.09.2023
Date of first issue: 15.10.2014

Causes damage to organs through prolonged or repeatedexposure.
First Aid responders should pay attention to self-protection,and use the recommended personal protective equipment
when the potential for exposure exists (see section 8).

Indication of any immediate medical attention and special treatment needed
Treatment: Treat symptomatically and supportively.
Section 5: Fire-fighting measures
Extinguishing media
Suitable extinguishing media

Unsuitable extinguishing
media

:

:

Water spray
Alcohol-resistant foam
Carbon dioxide (CO2)
Dry chemical
None known.

Special hazards arising from the substance or mixture
Specific hazards during fire- : Exposure to combustion products may be a hazard to health.
fighting
Hazardous combustion prod- : No hazardous combustion products are known
ucts
Special protective actions for fire-fighters
Special protective equipment : In the event of fire, wear self-contained breathing apparatus.
for firefighters
Use personal protective equipment.
Specific extinguishing meth- : Use extinguishing measures that are appropriate to local cirods
cumstances and the surrounding environment.
Use water spray to cool unopened containers.
Remove undamaged containers from fire area if it is safe to doso.
Evacuate area.
Section 6: Accidental release measures
Personal precautions, protective equipment and emergency procedures
Personal precautions: Use personal protective equipment.
Follow safe handling advice (see section 7) and personal protective equipment recommendations (see section 8).
Environmental precautions
Environmental precautions:

Avoid release to the environment.
Prevent further leakage or spillage if safe to do so.
Prevent spreading over a wide area (e.g. by containment or oilbarriers).
Retain and dispose of contaminated wash water.
Local authorities should be advised if significant spillages
cannot be contained.

Methods and materials for containment and cleaning up
3 / 13

SAFETY DATA SHEET

Ganirelix Formulation
Version
6.0

Revision Date:
06.04.2024

Methods for cleaning up

SDS Number:
22223-00022:

Date of last issue: 26.09.2023
Date of first issue: 15.10.2014

Soak up with inert absorbent material.
For large spills, provide dyking or other appropriate containment to keep material from spreading. If dyked material canbe pumped, store recovered material in appropriate container.
Clean up remaining materials from spill with suitable absorbent.
Local or national regulations may apply to releases and disposal of this material, as well as those materials and items
employed in the cleanup of releases. You will need to determine which regulations are applicable.
Sections 13 and 15 of this SDS provide information regarding
certain local or national requirements.

Section 7: Handling and storage
Precautions for safe handlingTechnical measures:
Local/Total ventilation:

Advice on safe handling:

Hygiene measures:

See Engineering measures under EXPOSURE
CONTROLS/PERSONAL PROTECTION section.
If sufficient ventilation is unavailable, use with local exhaust
ventilation.
Do not get on skin or clothing.
Do not breathe mist or vapours.
Do not swallow.
Avoid contact with eyes.
Wash skin thoroughly after handling.
Handle in accordance with good industrial hygiene and safety
practice, based on the results of the workplace exposure assessment
Keep container tightly closed.
Do not eat, drink or smoke when using this product.
Take care to prevent spills, waste and minimize release to theenvironment.
If exposure to chemical is likely during typical use, provide eye
flushing systems and safety showers close to the working
place.
When using do not eat, drink or smoke.
Wash contaminated clothing before re-use.
The effective operation of a facility should include review ofengineering controls, proper personal protective equipment,
appropriate degowning and decontamination procedures,industrial hygiene monitoring, medical surveillance and theuse of administrative controls.

Conditions for safe storage, including any incompatibilities
Conditions for safe storage: Keep in properly labelled containers.
Store locked up.
Keep tightly closed.
Store in accordance with the particular national regulations.
Materials to avoid: Do not store with the following product types:
Strong oxidizing agents

4 / 13

SAFETY DATA SHEET

Ganirelix Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
22223-00022

Date of last issue: 26.09.2023
Date of first issue: 15.10.2014

Section 8: Exposure controls/personal protection
Control parameters
Occupational Exposure Limits
Components

CAS-No.

Ganirelix

124904-93-4

Value type
(Form ofexposure)
TWA
Wipe limit

Appropriate engineering
control measures:

Control parameters / Permissible
concentration
0.2 µg/m3 (OEB
5)
2 µg/100 cm²

Basis

Internal
Internal

Use closed processing systems or containment technologies
to control at source (e.g., glove boxes/isolators) and to prevent leakage of compounds into the workplace.
All engineering controls should be implemented by facility
design and operated in accordance with GMP principles toprotect products, workers, and the environment.
No open handling permitted.
Totally enclosed processes and materials transport systems
are required.
Operations require the use of appropriate containment technology designed to prevent leakage of compounds into theworkplace.

Individual protection measures, such as personal protective equipment (PPE)
Eye/face protection: Wear safety glasses with side shields or goggles.
If the work environment or activity involves dusty conditions,mists or aerosols, wear the appropriate goggles.
Wear a faceshield or other full face protection if there is apotential for direct contact to the face with dusts, mists, oraerosols.
Skin protection: Work uniform or laboratory coat.
Additional body garments should be used based upon thetask being performed (e.g., sleevelets, apron, gauntlets, disposable suits) to avoid exposed skin surfaces.
Use appropriate degowning techniques to remove potentiallycontaminated clothing.
Respiratory protection: No personal respiratory protective equipment normally required.
Hand protection
Material:

Chemical-resistant gloves

Remarks:

Consider double gloving.

Section 9: Physical and chemical properties
Appearance:

Aqueous solution

5 / 13

SAFETY DATA SHEET

Ganirelix Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
22223-00022

Date of last issue: 26.09.2023
Date of first issue: 15.10.2014

Colour:No data available

Odour

:

No data available

Odour Threshold:

No data available

pH

:

5

Melting point/freezing point:

No data available

Initial boiling point and boiling
range

:

100 °CFlash point:

No data available

Evaporation rate:

No data available

Flammability (solid, gas):

Not applicable

Flammability (liquids):

No data available

Upper explosion limit / Upper
flammability limit:

No data available

Lower explosion limit / Lower
flammability limit:

No data available

Vapour pressure:

23 hPa (20 °C)

Relative vapour density:

No data available

Relative density:

1

Solubility(ies)
Water solubility:

completely miscible

Partition coefficient: noctanol/water
Auto-ignition temperature:

No data available:

No data available

Decomposition temperature:

No data available

Viscosity
Viscosity, kinematic:

No data available

Explosive properties:

Not explosive

Oxidizing properties:

The substance or mixture is not classified as oxidizing.

Molecular weight:

No data available

6 / 13

SAFETY DATA SHEET

Ganirelix Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
22223-00022

Particle characteristics
Particle size

Date of last issue: 26.09.2023
Date of first issue: 15.10.2014:

No data available:::

Not classified as a reactivity hazard.
Stable under normal conditions.
Can react with strong oxidizing agents.

:::

None known.
Oxidizing agents
No hazardous decomposition products are known.

Section 10: Stability and reactivity
Reactivity
Chemical stability
Possibility of hazardous reactions
Conditions to avoid
Incompatible materials
Hazardous decomposition
products

Section 11: Toxicological information
Information on likely routes of :exposure

Inhalation
Skin contact
Ingestion
Eye contact

Acute toxicity
Not classified based on available information.
Components:
Ganirelix:
Acute toxicity (other routes of :administration)

LD50 (Rat): 40 mg/kg

Skin corrosion/irritation
Not classified based on available information.
Serious eye damage/eye irritation
Not classified based on available information.
Components:
Ganirelix:SpeciesResult
Method:::RabbitMild eye irritation
Draize Test

Respiratory or skin sensitisation
Skin sensitisation
Not classified based on available information.
Respiratory sensitisation
Not classified based on available information.

7 / 13

SAFETY DATA SHEET

Ganirelix Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
22223-00022

Date of last issue: 26.09.2023
Date of first issue: 15.10.2014

Components:
Ganirelix:
Test TypeSpeciesResult:::Maximisation Test
Guinea pig
negative

Germ cell mutagenicity
Not classified based on available information.
Components:
Ganirelix:
Genotoxicity in vitro:

Test Type: reverse mutation assay
Test system: Salmonella typhimurium
Result: negative
Test Type: reverse mutation assay
Test system: Escherichia coli
Result: negative
Test Type: in vitro assay
Test system: Chinese hamster ovary cells
Result: negative

Genotoxicity in vivo:

Test Type: In vivo micronucleus test
Species: Mouse
Application Route: Intravenous
Result: negative

Germ cell mutagenicity Assessment:

Weight of evidence does not support classification as a germ
cell mutagen.

Carcinogenicity
Not classified based on available information.
Reproductive toxicity
May damage fertility. Suspected of damaging the unborn child.
Components:
Ganirelix:
Effects on fertility:

Test Type: Fertility/early embryonic development
Species: Rat
Application Route: Subcutaneous
Duration of Single Treatment: 13 Weeks
Fertility: LOAEL: 0.1 µg/kg
Result: Effects on fertility
Test Type: Fertility/early embryonic development
Species: Rat, female
Application Route: Subcutaneous
8 / 13

SAFETY DATA SHEET

Ganirelix Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
22223-00022

Date of last issue: 26.09.2023
Date of first issue: 15.10.2014

Duration of Single Treatment: 8 Weeks
Fertility: LOAEL: 10 µg/kg
Result: No effects on mating performance, Effects on fertility
Test Type: Fertility
Species: Monkey
Application Route: Subcutaneous
Fertility: NOAEL: 0.02 mg/kg body weight
Result: Effects on fertility
Effects on foetal development:

Test Type: Embryo-foetal development
Species: Rat, female
Application Route: Subcutaneous
Embryo-foetal toxicity: LOAEL: 10 µg/kg
Result: Embryo-foetal toxicity
Test Type: Embryo-foetal development
Species: Rabbit, female
Application Route: Subcutaneous
Embryo-foetal toxicity: LOAEL: 30 µg/kg
Result: Embryo-foetal toxicity

Reproductive toxicity - Assessment:

Clear evidence of adverse effects on sexual function and fertility, based on animal experiments., Some evidence of adverse
effects on development, based on animal experiments.

STOT - single exposure
Not classified based on available information.
STOT - repeated exposure
Causes damage to organs (Bone marrow, Liver, Adrenal gland, spleen, Ovary) through prolonged
or repeated exposure.
Components:
Ganirelix:
Exposure routes
Target Organs
Assessment:::

Ingestion
Bone marrow, Liver, Adrenal gland, spleen, Ovary
Causes damage to organs through prolonged or repeatedexposure.

:
:
:
:
:
:

Rat
0.02 mg/kg
2 mg/kg
Subcutaneous
6 Months
Bone marrow

Repeated dose toxicity
Components:
Ganirelix:Species
NOAEL
LOAEL
Application RouteExposure timeTarget Organs

9 / 13

SAFETY DATA SHEET

Ganirelix Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
22223-00022

Date of last issue: 26.09.2023
Date of first issue: 15.10.2014

Species
LOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:

Mouse, female
0.3 mg/kg
Subcutaneous
3 Months
Liver, Adrenal gland, spleen, Ovary

Species
LOAEL
Application RouteExposure timeTarget Organs

:
:
:
:
:

Mouse, male
3 mg/kg
Subcutaneous
3 Months
Liver, Adrenal gland, spleenSpecies
NOAEL
Application RouteExposure time
Remarks:::::

Monkey2.5 mg/kg
Subcutaneous
6 Months
No significant adverse effects were reported

Aspiration toxicity
Not classified based on available information.
Experience with human exposure
Components:
Ganirelix:
Inhalation:

Symptoms: The most common side effects are:, vaginal
bleeding, Headache, Abdominal pain, Nausea, ectopic pregnancy, miscarriage

Section 12: Ecological information
Toxicity
Components:
Ganirelix:
Ecotoxicology Assessment
Acute aquatic toxicity:

No data available

Chronic aquatic toxicity

No data available:

Persistence and degradability
No data available
Bioaccumulative potential
No data available
Mobility in soil
No data available
10 / 13SAFETY DATA SHEET

Ganirelix Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
22223-00022

Date of last issue: 26.09.2023
Date of first issue: 15.10.2014

Other adverse effects
No data available
Section 13: Disposal considerations
Disposal methods
Waste from residues:

Contaminated packaging:

Do not dispose of waste into sewer.
Dispose of in accordance with local regulations.
Empty containers should be taken to an approved waste handling site for recycling or disposal.
If not otherwise specified: Dispose of as unused product.

Section 14: Transport information
International Regulations
UNRTDGUN numberUN proper shipping name
Transport hazard class(es)Subsidiary risk
Packing group
LabelsEnvironmentally hazardous
IATA-DGR
UN/ID No.
UN proper shipping nameClass
Subsidiary risk
Packing group
LabelsPacking instruction (cargo
aircraft)Packing instruction (passenger aircraft)
IMDG-CodeUN numberUN proper shipping nameClass
Subsidiary risk
Packing group
LabelsEmS Code
Marine pollutant

:
:
:
:
:
:
:

Not applicableNot applicableNot applicableNot applicableNot applicableNot applicable
no

:
:
:
:
:
:
:

Not applicableNot applicableNot applicableNot applicableNot applicableNot applicableNot applicable:Not applicable

:
:
:
:
:
:
:
:

Not applicableNot applicableNot applicableNot applicableNot applicableNot applicableNot applicableNot applicable

Transport in bulk according to IMO instruments
Not applicable for product as supplied.
Special precautions for user
Not applicable

11 / 13SAFETY DATA SHEET

Ganirelix Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
22223-00022

Date of last issue: 26.09.2023
Date of first issue: 15.10.2014

Section 15: Regulatory information
Safety, health and environmental regulations specific for the product in question
Workplace Safety and Health Act and Workplace Safety and Health (General Provisions) Regulations: This product is subjected to the SDS, labelling, PEL and other requirements in the
Act/Regulations.
Environmental Protection and Management Act and: Not applicable
Environmental Protection and Management (Hazardous Substances) Regulations
Fire Safety (Petroleum and Flammable Materials)
Regulations:

Not applicable

The components of this product are reported in the following inventories:
AICS: not determinedDSL:

not determined

IECSC

:

not determined

Revision Date:

06.04.2024

Further information
Sources of key data used tocompile the Safety Data
Sheet

:

Internal technical data, data from raw material SDSs, OECD
eChem Portal search results and European Chemicals Agency, http://echa.europa.eu/

Section 16: Other information

Items where changes have been made to the previous version are highlighted in the body of thisdocument by two vertical lines.
Date format:

dd.mm.yyyy

Full text of other abbreviations

AIIC - Australian Inventory of Industrial Chemicals; ANTT - National Agency for Transport byLand of Brazil; ASTM - American Society for the Testing of Materials; bw - Body weight; CMR Carcinogen, Mutagen or Reproductive Toxicant; DIN - Standard of the German Institute forStandardisation; DSL - Domestic Substances List (Canada); ECx - Concentration associated with
x% response; ELx - Loading rate associated with x% response; EmS - Emergency Schedule;
ENCS - Existing and New Chemical Substances (Japan); ErCx - Concentration associated with
x% growth rate response; ERG - Emergency Response Guide; GHS - Globally Harmonized System; GLP - Good Laboratory Practice; IARC - International Agency for Research on Cancer; IATA
- International Air Transport Association; IBC - International Code for the Construction andEquipment of Ships carrying Dangerous Chemicals in Bulk; IC50 - Half maximal inhibitory concentration; ICAO - International Civil Aviation Organization; IECSC - Inventory of Existing Chemical Substances in China; IMDG - International Maritime Dangerous Goods; IMO - International
12 / 13SAFETY DATA SHEET

Ganirelix Formulation
Version
6.0

Revision Date:
06.04.2024

SDS Number:
22223-00022

Date of last issue: 26.09.2023
Date of first issue: 15.10.2014

Maritime Organization; ISHL - Industrial Safety and Health Law (Japan); ISO - International Organisation for Standardization; KECI - Korea Existing Chemicals Inventory; LC50 - Lethal Concentration to 50 % of a test population; LD50 - Lethal Dose to 50% of a test population (Median
Lethal Dose); MARPOL - International Convention for the Prevention of Pollution from Ships;
n.o.s. - Not Otherwise Specified; Nch - Chilean Norm; NO(A)EC - No Observed (Adverse) EffectConcentration; NO(A)EL - No Observed (Adverse) Effect Level; NOELR - No Observable EffectLoading Rate; NOM - Official Mexican Norm; NTP - National Toxicology Program; NZIoC - New
Zealand Inventory of Chemicals; OECD - Organization for Economic Co-operation and Development; OPPTS - Office of Chemical Safety and Pollution Prevention; PBT - Persistent, Bioaccumulative and Toxic substance; PICCS - Philippines Inventory of Chemicals and Chemical Substances; (Q)SAR - (Quantitative) Structure Activity Relationship; REACH - Regulation (EC) No
1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals; SADT - Self-Accelerating Decomposition Temperature; SDS - Safety Data Sheet; TCSI - Taiwan Chemical Substance Inventory; TDG - Transportation of Dangerous Goods; TECI - Thailand Existing Chemicals Inventory; TSCA - Toxic Substances Control Act (United States); UN - United Nations; UNRTDG - United Nations Recommendations on the Transport of Dangerous Goods; vPvB - Very Persistent and Very Bioaccumulative; WHMIS - Workplace Hazardous Materials Information System
The information provided in this Safety Data Sheet is correct to the best of our knowledge, information and belief at the date of its publication. The information is designed only as a guidance forsafe handling, use, processing, storage, transportation, disposal and release and shall not be
considered a warranty or quality specification of any type. The information provided relates only
to the specific material identified at the top of this SDS and may not be valid when the SDS material is used in combination with any other materials or in any process, unless specified in the text.
Material users should review the information and recommendations in the specific context of theirintended manner of handling, use, processing and storage, including an assessment of the appropriateness of the SDS material in the user’s end product, if applicable.
SG / EN

13 / 13